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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX GENERAL ANESTHESIA CIRCUITS CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIEC

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NULL PORTEX GENERAL ANESTHESIA CIRCUITS CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIEC Back to Search Results
Catalog Number C37101329-NLJ
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2022
Event Type  malfunction  
Event Description
It was reported that during the pre-use check, the breathing bag was found partially torn. No patient involvement. No additional information is available for this complaint.
 
Event Description
It was reported that during the pre-use check, the breathing bag was found partially torn. No patient involvement. No additional information is available for this complaint.
 
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Brand NamePORTEX GENERAL ANESTHESIA CIRCUITS
Type of DeviceCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIEC
Manufacturer (Section G)
NULL
MDR Report Key13604035
MDR Text Key286256022
Report Number3012307300-2022-04172
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 05/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberC37101329-NLJ
Device Lot Number20713423
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/07/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1515-2021, Z-1516-2021

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